New Specification for
non-sterile isolation gowns intended for use in health care facilities

WK33313

1. Scope

Scope: Develop a standard specification for non-sterile isolation gowns intended for use by health care workers to provide protection for contact isolation and for minimal to moderate fluid exposure risk. Out of scope: Surgical gowns, sterile gowns, and gowns used for chemotherapy drug contact

F 23.40 has heard from user groups (AORN and APIC) as well as FDA that performance properties and levels of protection for these products are poorly understood and defined. Development of a standard will improves users understanding of levels of protection to be provided. FDA will likely adopt the finished document as a consensus standard.

Keywords

Barrier, tensile, linting, comfort, hydrohead

The title and scope are in draft form and are under development within this ASTM Committee.